FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
Medical device recall Z-0087-2022. Published in FDA’s Enforcement Report on Oct 20, 2021.
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 Oct 20, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 262 total, 52 US 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 Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Improper management of the sample may bring an incorrect patient result.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
262 total, 52 US, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Impacted Module: ADVIA Centaur XP/XPT Interface Module, Part No. FLX-021-00; FLX-021-10; APT-021-00 Serial numbers: ***FLEXLAB*** FLX.0109 FLX.0127 FLX.0128 FLX.0129 FLX.0132 FLX.0133 FLX.0139 FLX.0146 FLX.0147 FLX.0149 FLX.0151 FLX.0153…
Every code shown here, 1,995 characters
Impacted Module: ADVIA Centaur XP/XPT Interface Module, Part No. FLX-021-00; FLX-021-10; APT-021-00 Serial numbers: ***FLEXLAB*** FLX.0109 FLX.0127 FLX.0128 FLX.0129 FLX.0132 FLX.0133 FLX.0139 FLX.0146 FLX.0147 FLX.0149 FLX.0151 FLX.0153 FLX.0154 FLX.0156 FLX.0157 FLX.0159 FLX.0160 FLX.0162 FLX.0165 FLX.0166 FLX.0167 FLX.0169 FLX.0170 FLX.0172 FLX.0173 FLX.0174 FLX.0179 FLX.0180 FLX.0182 FLX.0191 FLX.0192 FLX.0193 FLX.0194 FLX.043 FLX.069 FLX.085 FLX.086 FLX.087 FLX.093 FLX.097 ***ACCELERATOR a3600*** ACP.334 ***APTIO AUTOMATION*** AP2.0002 AP2.0003 AP2.0004 AP2.0005 AP2.0006 AP2.0007 AP2.0008 AP2.009 AP2.0010 AP2.0011 AP2.0012 AP2.0014 AP2.0015 AP2.0016 AP2.0017 AP2.0018 AP2.0019 AP2.0022 AP2.0023 AP2.0024 AP2.0025 AP2.0026 AP2.0027 AP2.0028 AP2.0029 AP2.0031 AP2.0032 AP2.0033 AP2.0035 AP2.0037 AP2.0038 AP2.0039 AP2.0040 AP2.0041 AP2.0043 AP2.0045 AP2.0046 AP2.0047 AP2.0048 AP2.0049 AP2.0050 AP2.0051 AP2.0052 AP2.0053 AP2.0054 AP2.0055 AP2.0057 AP2.0058 AP2.0059 AP2.0061 AP2.0062 AP2.0063 AP2.0064 AP2.0065 AP2.0066 AP2.0067 AP2.0070 AP2.0075 AP2.0076 AP2.0077 AP2.0078 AP2.0079 AP2.0080 AP2.0081 AP2.0082 AP2.0083 AP2.0084 AP2.0085 AP2.0087 AP2.0088 AP2.0089 AP2.0090 AP2.0091 AP2.0092 AP2.0093 AP2.0094 AP2.0095 AP2.0097 AP2.0098 AP2.0100 AP2.0102 AP2.0103 AP2.0104 AP2.0105 AP2.0106 AP2.0107 AP2.0108 AP2.0109 AP2.0110 AP2.0111 AP2.0112 AP2.0115 AP2.0117 AP2.0118 AP2.0119 AP2.0122 AP2.0123 AP2.0124 AP2.0126 AP2.0127 AP2.0128 AP2.0129 AP2.0131 AP2.0132 AP2.0133 AP2.0135 AP2.0136 AP2.0137 AP2.0138 AP2.0141 AP2.0142 AP2.0144 AP2.0145 AP2.0147 AP2.0149 AP2.0150 AP2.0153 AP2.0155 AP2.0156 AP2.0160 AP2.0161 AP2.0162 AP2.0165 AP2.0166 AP2.0168 AP2.0173 AP2.0178 AP2.0179 AP2.0180 AP2.0182 AP2.0186 AP2.0190 AP2.0191 AP2.0192 AP2.0193 AP2.0195 AP2.0198 AP2.0199 AP2.0200 AP2.0204 AP2.0205 AP2.0206 AP2.0207 AP2.0208 AP2.0212 AP2.0216 AP2.0219 AP2.0221 AP2.0222 AP2.0223 AP2.0226 AP2.0233 AP2.0235 AP2.0236 AP2.0237 AP2.0238 AP2.0239 AP2.0243 AP2.0244 AP2.0245 AP2.0247 AP2.0249…
FDA’s list runs to 2,531 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.
Domestic distribution nationwide . Foreign distribution worldwide.
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Sep 10, 2021.
- FDA classified it on Oct 12, 2021.
- FDA’s Enforcement Report published it on Oct 20, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Inpeco S.A., of Lugano, Switzerland.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: N/A.
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 2,531 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
-
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.