CLASS II ONGOING Device recall · Reported 17 May 2023 · FDA Enforcement Report
BioPlex 2200 REF 665-2050, Apls IgM Pack, Apls IgM Reagent Pack recalled
Bio-Rad Laboratories is recalling BioPlex 2200 REF 665-2050, Apls IgM Pack, Apls IgM Reagent Pack, distributed nationwide in the US. The recall was initiated on 28 Feb 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1572-2023
- FDA event ID
- 91889
- Recalling firm
- Bio-Rad Laboratories, Redmond, WA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Feb 2023
- FDA classified
- 10 May 2023
- Reported
- 17 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Test Kits & Diagnostics
Timeline
| 28 Feb 2023 | Recall initiated by company | |
| 10 May 2023 | Classified by FDA | +71 days |
| 17 May 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
Where it was distributed
US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, FL, HI, IL, IN, KS, KY, LA, MI, MO, NC, ND, NE, NJ, NM, NY, OH, OK, PR,SC, TN, TX, UT, VT.
Nationwide AlabamaArkansasArizonaCaliforniaConnecticutFloridaHawaiiIllinoisIndianaKansasKentuckyLouisianaMichiganMissouriNorth CarolinaNorth DakotaNebraskaNew JerseyNew MexicoNew York
Questions about this recall
Why was it recalled?
APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.
Which lots are affected?
Lot Code: 301538; UDI-DI: (00)847865000666
Where was it sold?
US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, FL, HI, IL, IN, KS, KY, LA, MI, MO, NC, ND, NE, NJ, NM, NY, OH, OK, PR,SC, TN, TX, UT, VT.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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