Hearth Record

Perkin Elmer WIZARD2 1-detector,3”, 1000 samples

Medical device recall Z-2130-2015. Published in FDA’s Enforcement Report on Jul 29, 2015.

FDA’s own record, on accessdata.fda.gov

No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.

The short answer

Published in FDA’s Enforcement Report on Jul 29, 2015. Copied from openFDA on Oct 20, 2026.

Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.

How serious is it, by FDA’s class?

Class II, the middle of FDA’s three classes.

“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”

openFDA, in plain words, its enforcement report fields.

“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

FDA’s rule, 21 CFR 7.3(m)(2), eCFR.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

Perkin Elmer WIZARD2 1-detector,3”, 1000 samples Product Code: 2480-0010 The Wizard¿” gamma counter is intended to detect and count gamma radiation emitted by clinical samples.

179 units, in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

Serial Numbers: DG01130076 DG01130081 DG01130107 DG01130113 DG02130148 DG02130157 DG02130171 DG02130172 DG02130174 DG02130176 DG03129032 DG03130218 DG03130220 DG03130223 DG03130225 DG03130227 DG03130240 DG03130247 DG04106271 DG04129101…

Every code shown here, 1,992 characters

Serial Numbers: DG01130076 DG01130081 DG01130107 DG01130113 DG02130148 DG02130157 DG02130171 DG02130172 DG02130174 DG02130176 DG03129032 DG03130218 DG03130220 DG03130223 DG03130225 DG03130227 DG03130240 DG03130247 DG04106271 DG04129101 DG04129141 DG04129168 DG05129187 DG05129210 DG05129256 DG05129258 DG06117938 DG06129274 DG06129282 DG06129289 DG06129333 DG06129336 DG06129341 DG06129343 DG06129345 DG06129346 DG06129354 DG07129436 DG07129444 DG07129445 DG07129446 DG07129448 DG07129449 DG08118168 DG08118169 DG08129491 DG08129502 DG08129505 DG08129506 DG08129544 DG08129545 DG08129595 DG09129607 DG09129622 DG09129623 DG09129644 DG10129700 DG10129708 DG10129717 DG10129726 DG10129759 DG10129763 DG10129777 DG10129784 DG11095721 DG11129816 DG11129823 DG11129839 DG11129854 DG12120039 DG12129887 DG12129893 DG12129902 DG12129903 DG12129904 DG12129905 DG12129931 DG12129932 SGWZ02140095 SGWZ02140096 SGWZ02140097 SGWZ02150231 SGWZ03150233 SGWZ04150236 SGWZ04150237 SGWZ07140106 SGWZ07150245 SGWZ08140109 SGWZ08140110 SGWZ08140111 SGWZ08150246 SGWZ09140112 SGWZ10140115 SGWZ10150250 SGWZ11150253 SGWZ12140120 SGWZ12140121 SGWZ12140122 SGWZ13140123 SGWZ13140124 SGWZ14130004 SGWZ15140127 SGWZ15140129 SGWZ17130005 SGWZ18140138 SGWZ19140142 SGWZ19140143 SGWZ20130008 SGWZ20140146 SGWZ20140149 SGWZ21140153 SGWZ22130013 SGWZ22130014 SGWZ22140155 SGWZ22140156 SGWZ23130015 SGWZ23140157 SGWZ24140158 SGWZ25130020 SGWZ27140162 SGWZ27140165 SGWZ28140167 SGWZ29140170 SGWZ30140172 SGWZ30140173 SGWZ31130029 SGWZ31140177 SGWZ31140178 SGWZ32130031 SGWZ32140181 SGWZ32140182 SGWZ33130032 SGWZ33130033 SGWZ34140186 SGWZ35130037 SGWZ35140187 SGWZ35140189 SGWZ36130041 SGWZ36140191 SGWZ36140194 SGWZ37130045 SGWZ37140195 SGWZ39130047 SGWZ39140197 SGWZ39140198 SGWZ40140199 SGWZ40140200 SGWZ41130049 SGWZ42130050 SGWZ42140201 SGWZ42140202 SGWZ42140203 SGWZ43130055 SGWZ44130059 SGWZ44130060 SGWZ44140210 SGWZ44140211 SGWZ45130064 SGWZ45130066 SGWZ45140212 SGWZ45140213 SGWZ45140214 SGWZ46130069 SGWZ46130070…

FDA’s list runs to 2,186 characters. The first part is shown; the rest is on FDA’s record.

Source:

Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.

Where did it go?

FDA’s words for the “general area of initial distribution”: where the firm first shipped it.

Worldwide Distribution-US (nationwide) and the countries of ARGENTINA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CHILE CHINA COSTA RICA CROATIA CZECH REPUBLIC DENMARK ETHIOPIA FINLAND FRANCE GERMANY GREECE HONG KONG HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA KUWAIT LUXEMBOURG MEXICO MYANMAR NETHERLANDS NORWAY PHILIPPINES POLAND REUNION SAUDIA ARABIA SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UK.

These words name no state.

What FDA means by nationwide

“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”

openFDA, its enforcement report fields.

The words say it went outside the United States too.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

Is it still going on?

Terminated, in FDA’s file.

“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”

openFDA, on “Terminated”, its enforcement report fields.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Jun 3, 2015.
  • FDA classified it on Jul 20, 2015.
  • FDA’s Enforcement Report published it on Jul 29, 2015.
  • FDA terminated it on Aug 4, 2017.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Who is recalling it?

  • Perkinelmer, of Waltham, MA.
  • Who began it, in FDA’s words: Voluntary: Firm initiated.
  • How the firm first told its customers: Letter.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

What this record can’t tell you

  • Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
  • Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
  • How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
  • Whether anyone was hurt or fell ill: the report doesn’t say.
  • How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
  • FDA’s list of codes runs to 2,186 characters; the first part is shown here, and the rest is on FDA’s record.
  • A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Source:

Hearth Record wrote these lines; the quotations are FDA’s.

Sources

  • U.S. Food and Drug Administration, Device recall enforcement reports.

    Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.

Source:

Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

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Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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