FDA Device recall Z-1563-2021
Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator
- FDA Device
- Class II
- terminated
- Published 2021-05-19
On 2021-05-19 the FDA classified a Class II recall of Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator by Randox Laboratories, citing randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using calibrator CAL2351, lot 1162UE. The positive bias has….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1563-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-29 |
| Published | 2021-05-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Randox Laboratories |
| Distribution | CA, CT, DC, IL, IN, MA, MD, MN, MS, NE, NJ, NY, OR, PR, TX, VA |
Product
Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
Reason
Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using calibrator CAL2351, lot 1162UE. The positive bias has been attributed to bilirubin instability in the calibrator and is evident in both Quality Control (QC) and Patient samples.
Identifiers
| code_info | Batch / Lot number: 1162UE GTIN: 05055273200966 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1563-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.