Recall Z-1100-2020 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Randox Laboratories Ltd.
Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
| Date | Dec 13, 2019 |
| Status | Terminated |
| 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). |
| Root cause | Error in labeling |
| Action | On December 13, 2019 the firm distributed Urgent Medical Device Recall letters by e-mail stating: Urgent Medical Device Correction Complaint Reference: REC430 Action Type: Device Modification Our records indicate that your facility may have received the following product Detail on Affected Devices: Liquid Clinical Chemistry Control Catalogue Number: LAE4217 GTIN: 05055273208993 Lot Number: 1021UE Expiration Date: 30June2020 Manufacturing Date: 21Oct2018 Reason for Recall: A transcription error has occurred for the Randox Lipase colorimetric value in Liquid Clinical Chemistry Control lot 1021 |
| Quantity | 2 |
| Distribution | US: NY and DE OUS: France, Lithuania, Poland, Spain, Switzerland, Turkey, Australia, Hong Kong, Bosnia and Herzegovina, Costa Rica, Ecuador, Gambia, New Zealand and Solomon Islands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.