CLASS II ONGOING Device recall · Reported 5 Apr 2023 · FDA Enforcement Report
CRP Immunoturbidimetric reagent recalled by Randox Laboratories
Randox Laboratories is recalling CRP Immunoturbidimetric reagent, distributed in Ohio, Pennsylvania, West Virginia. The recall was initiated on 1 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-1286-2023
- FDA event ID
- 91745
- Recalling firm
- Randox Laboratories, Kearneysville, WV
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Feb 2023
- FDA classified
- 24 Mar 2023
- Reported
- 5 Apr 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 1 Feb 2023 | Recall initiated by company | |
| 24 Mar 2023 | Classified by FDA | +51 days |
| 5 Apr 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be within range
Product as listed by the FDA
CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826
Where it was distributed
PA, OH, WV
Questions about this recall
Why was it recalled?
The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be within range
Which lots are affected?
GTIN: 05055273201765 Batch: 588434
Where was it sold?
PA, OH, WV
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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