CLASS II ONGOING Device recall · Reported 19 Apr 2023 · FDA Enforcement Report

BioPlex 2200, Anti-CCP Calibrator Set recalled by Bio-Rad Laboratories

Bio-Rad Laboratories is recalling BioPlex 2200, Anti-CCP Calibrator Set, distributed nationwide in the US. The recall was initiated on 21 Feb 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 53727; UDI GTIN: 00847865000819

Quantity recalled225 units

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-1378-2023
FDA event ID: 91854
Recalling firm: Bio-Rad Laboratories, Redmond, WA
Classification: Class II
Status: Ongoing
Recall initiated: 21 Feb 2023
FDA classified: 12 Apr 2023
Reported: 19 Apr 2023
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

21 Feb 2023	Recall initiated by company
12 Apr 2023	Classified by FDA	+50 days
19 Apr 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

Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positivesBio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positivesBio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positives.There is no performance issue with the calibrator lot# 53727. They are included in the recall only because the calibrators are lot matched to the impacted reagent pack.

Product as listed by the FDA

BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic, Germany, Spain, France, United Kingdom, Israel, Italy, Norway, Sweden.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot # 53727; UDI GTIN: 00847865000819

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic, Germany, Spain, France, United Kingdom, Israel, Italy, Norway, Sweden.

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 91854

Reported	Class	Recall	Company	Reason	Where
19 Apr 2023	CLASS II	BioPlex 2200, Anti-CCP Reagent Pack recalled by Bio-Rad Laboratories	Bio-Rad Laboratories	Other	Nationwide

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