CLASS II ONGOING Device recall · Reported 27 Mar 2024 · FDA Enforcement Report
Liquid Protein Calibrators recalled by Randox Laboratories
Randox Laboratories is recalling Liquid Protein Calibrators, distributed in 7 states. The recall was initiated on 1 Mar 2024 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-1328-2024
- FDA event ID
- 94187
- Recalling firm
- Randox Laboratories, Crumlin (North)
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Mar 2024
- FDA classified
- 20 Mar 2024
- Reported
- 27 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 1 Mar 2024 | Recall initiated by company | |
| 20 Mar 2024 | Classified by FDA | +19 days |
| 27 Mar 2024 | 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
The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
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
Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
Where it was distributed
Domestic: CA, FL, IL, ME, NJ, OH, & OR.
Questions about this recall
Is Liquid Protein Calibrators recalled?
Yes. Randox Laboratories recalled Liquid Protein Calibrators on 1 Mar 2024. The recall is Class II and its status is Ongoing. Recall number Z-1328-2024.
Why was it recalled?
The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
Which lots are affected?
Catalog No. IT2691; GTIN 05055273204032; Batch No./Lot No. (Exp. Date): 647343/2154IT-2158IT (03/28/25), 647342/2154IT-2158IT (03/28/25), 634886/2112IT-2116IT (07/28/24), 634887/2112IT-2116IT (07/28/24), 627224/2112IT-2116IT (07/28/24), 627222/2112IT-2116IT (07/28/24)
Where was it sold?
Domestic: CA, FL, IL, ME, NJ, OH, & OR.
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 21 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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