CLASS II ONGOING Device recall · Reported 11 Jan 2023 · FDA Enforcement Report
Liquid Assayed Specific Protein Control Level vitro recalled
Randox Laboratories is recalling Liquid Assayed Specific Protein Control Level vitro diagnostic use, in the quality, distributed nationwide in the US. The recall was initiated on 22 Nov 2022 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-0904-2023
- FDA event ID
- 91225
- Recalling firm
- Randox Laboratories, Crumlin (North), N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Nov 2022
- FDA classified
- 5 Jan 2023
- Reported
- 11 Jan 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 22 Nov 2022 | Recall initiated by company | |
| 5 Jan 2023 | Classified by FDA | +44 days |
| 11 Jan 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
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 Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683
Where it was distributed
US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.
Nationwide CaliforniaFloridaMaineMissouriNorth CarolinaNew JerseyOhioPennsylvaniaTennessee
Questions about this recall
Why was it recalled?
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
Which lots are affected?
GTIN: 05055273204902 Lot Number/Exp. Date: 585LPC 28thJun 23; 601LPC 28th Nov 23; 612LPC 28th Sep 24
Where was it sold?
US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.
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
2 other products · FDA event 91225| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Liquid Assayed Specific Protein- In vitro diagnostic use recalled | Randox Laboratories | Potency & Assay | Nationwide | |
| CLASS II | Liquid Assayed Specific Protein Control Level vitro recalled | Randox Laboratories | Potency & Assay | Nationwide |
More recalls from Randox Laboratories
All 98| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Randox Lipoprotein (a) - In vitro diagnostic recalled | Randox Laboratories | Device Malfunction | Nationwide |
| Device | CLASS II | Randox Lipoprotein (a) - In vitro diagnostic recalled | Randox Laboratories | Device Malfunction | Nationwide |
| Device | CLASS II | RX Series CYSC- Cystatin C Reagent -Intended recalled | Randox Laboratories | Potency & Assay | Nationwide |
| Device | CLASS II | Clinical Chemistry Calibration Serum recalled by Randox Laboratories | Randox Laboratories | Other | Nationwide |
| Device | CLASS III | Evidence MultiSTAT recalled by Randox Laboratories | Randox Laboratories | Packaging Defects | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,658| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Vitek 2 Ast-N461 Test Kit, Gram Negative Susceptibility recalled | Biomerieux | Other | MO |
| Device | CLASS II | DASH Rapid PCR Instrument recalled by Nuclein | Nuclein | Device Malfunction | Nationwide |
| Device | CLASS II | STA Staclot Protein recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |