CLASS II ONGOING Device recall · Reported 24 Nov 2021 · FDA Enforcement Report
Bio-rad BioPlex recalled by Bio-Rad Laboratories
Bio-Rad Laboratories is recalling Bio-rad BioPlex 2200, distributed nationwide in the US. The recall was initiated on 17 Sep 2021 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-0236-2022
- FDA event ID
- 88874
- Recalling firm
- Bio-Rad Laboratories, Redmond, WA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Sep 2021
- FDA classified
- 16 Nov 2021
- Reported
- 24 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 17 Sep 2021 | Recall initiated by company | |
| 16 Nov 2021 | Classified by FDA | +60 days |
| 24 Nov 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and 2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause elevated RPR reactivity potentially due to early shelf-life failure.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the calibration of the BioPlex 2200 Syphilis Total & RPR Reagent Pack.
Where it was distributed
Worldwide Distribution: U.S.(nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, and WV; O.U.S.(foreign) countries of: France, Germany, Israel, Italy, Russian Federation, South Africa, Spain, and Taiwan.
Nationwide AlaskaAlabamaArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaineMichiganMinnesotaMissouri
Questions about this recall
Why was it recalled?
Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and 2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause elevated RPR reactivity potentially due to early shelf-life failure.
Which lots are affected?
Catalog Number: 12000651 UDI Code: 03610520652770 Lot Number: 52953
Where was it sold?
Worldwide Distribution: U.S.(nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, and WV; O.U.S.(foreign) countries of: France, Germany, Israel, Italy, Russian Federation, South Africa, Spain, and Taiwan.
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.
Other products in this recall event
1 other product · FDA event 88874| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Bio-rad BioPlex recalled by Bio-Rad Laboratories | Bio-Rad Laboratories | Potency & Assay | Nationwide |
More recalls from Bio-Rad Laboratories
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Platelia Toxo IgM recalled by Bio-Rad Laboratories | Bio-Rad Laboratories | Potency & Assay | Nationwide |
| Device | CLASS II | Bio-Rad, REF: 12005660, QXDx Bcr-abl %IS Kit recalled | Bio-Rad Laboratories | Other | Nationwide |
| Device | CLASS II | BioPlex 2200 REF 665-2050, Apls IgM Pack, Apls IgM Reagent Pack recalled | Bio-Rad Laboratories | Packaging Defects | Nationwide |
| Device | CLASS II | BioPlex 2200, Anti-CCP Reagent Pack recalled by Bio-Rad Laboratories | Bio-Rad Laboratories | Other | Nationwide |
| Device | CLASS II | BioPlex 2200, Anti-CCP Calibrator Set recalled by Bio-Rad Laboratories | Bio-Rad Laboratories | Other | Nationwide |
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