FDA Device recall Z-1100-2020
Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
- FDA Device
- Class III
- terminated
- Published 2020-02-12
On 2020-02-12 the FDA classified a Class III recall of Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml by Randox Laboratories, citing A transcription error has occurred for the Randox Lipase colorimetric value in Liquid Clinical Chemistry Control lot 1021 UE. The target and range are listed as 50 U/L (40 - 60) a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1100-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-12-13 |
| Published | 2020-02-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Randox Laboratories |
| Distribution | DE, NY |
Product
Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
Reason
A transcription error has occurred for the Randox Lipase colorimetric value in Liquid Clinical Chemistry Control lot 1021 UE. The target and range are listed as 50 U/L (40 - 60) and should be 72U/L (58 - 86).
Identifiers
| code_info | Catalogue Number: LAE4217 GTIN: 05055273208993 Lot Number: 1021UE (EXP: 2020-06-28) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1100-2020%22
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