Perkin Elmer WIZARD2 1-detector,3”, 1000 samples
Medical device recall Z-0638-2016. Published in FDA’s Enforcement Report on Jan 20, 2016.
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 Jan 20, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 188 units how much, in FDA’s words
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.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results.
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
188 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: DG12107256 DG04106256 DG08118161 DG03117633 DG09118348 DG06117938 DG04106271 DG03117625 DG11118603 DG03129003 DG11107087 DG09118269 DG09118346 DG09118323 DG09118410 DG10118462 DG12118695 DG03129030 DG05117802 DG04129089…
Every code shown here, 1,992 characters
Serial Numbers: DG12107256 DG04106256 DG08118161 DG03117633 DG09118348 DG06117938 DG04106271 DG03117625 DG11118603 DG03129003 DG11107087 DG09118269 DG09118346 DG09118323 DG09118410 DG10118462 DG12118695 DG03129030 DG05117802 DG04129089 DG11107086 DG03117631 DG10118453 DG01117421 DG04106256_REWORK DG06106456 DG03106146 DG11118564 DG03129000 DG02106095 DG08106711 DG02128912 DG10106940 DG07118046 DG07118051 DG03117635 DG09118273 DG05117890 DG12118657 DG09118349 DG03117557 DG10118483 DG10118478 DG11107160 DG04129156 DG02106081 DG09118167 DG02128958 DG03129032 DG03117634 DG11118575 DG08118256 DG05106334 DG10106910 DG10106950 DG03117630 DG05106409 DG07106656 DG12107176 DG05106333 DG05117810 DG10106978 DG03106122 DG12107186 DG08106662 DG05117817 DG05117874 DG02128962 DG11118610 DG03129033 DG03129034 DG12118735 DG11107053 DG09118307 DG07118070 DG09118306 DG08118170 DG02128953 DG02128936 DG03129053 DG08118162 DG11118587 DG03129031 DG02128933 DG03129002 DG03129001 DG08118163 DG02128895 DG10118489 DG02117474 DG09118281 DG09118316 DG10106976 DG06117966 DG06106504 DG08118168 DG08118169 DG11118545 DG01128861 DG10118448 DG10118458 DG10118474 DG10118458 DG10118472 DG01128794 DG03129055 DG09118321 DG07118071 DG10118440 DG02128879 DG03117632 DG10118408 DG02128927 DG06106505 DG10118418 DG01128802 DG12118717 DG12118769 DG12118783 DG01106026 DG09106876 DG03129068 DG05106332 DG01105987 DG03106128 DG10118388 DG08118165 DG01128850 DG06117937 DG06117936 DG06117939 DG08118166 DG04117759 DG11118579 DG10118424 DG01128854 DG01128856 DG12107271 DG11118623 DG08118164 DG01128829 DG09118312 DG06117986 DG03106165 DG12118688 DG05117847 DG10118417 DG02128918 DG04106222 DG06106437 DG11118584 DG03117571 DG09118290 DG09106811 DG12107248 DG04106273 DG08106755 DG10106977 DG10106938 DG06117987 DG03106136 DG12118727 DG02128898 DG06106464 DG11107127 DG05106395 DG11107034 DG01128809 DG11118596 DG04129132 DG09106843 DG02117463 DG02106083 DG09118289 DG03117597 DG12107197 DG02117542 DG12118710 DG01128838…
FDA’s list runs to 2,090 characters. The first part is shown; the rest is on FDA’s record.
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, BOLIVIA, BRAZIL, CANADA, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, MYANMAR, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, and THAILAND.
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.
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.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 8, 2015.
- FDA classified it on Jan 12, 2016.
- FDA’s Enforcement Report published it on Jan 20, 2016.
- FDA terminated it on Aug 4, 2017.
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.
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 2,090 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.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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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.
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.