Z-1100-2020Class III

Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml

Name: Z-1100-2020 Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
Creator: Randox Laboratories Ltd.
Published: 2019-12-13
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2019-12-13 / Terminated / root cause: labeling and UDI

FDA source

Randox Laboratories Ltd. began a recall of Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml on 2019-12-13. FDA classified it as Class III and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1100-2020
Classification: Class III
Status: Terminated
Initiated: 2019-12-13
Posted: 2020-02-06
Terminated: 2020-10-02
Recalling firm: Randox Laboratories, Limited
Product: Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: 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 tag: labeling and UDI
FDA 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 UE. The target and range are listed as 50 U/L (40 - 60) and should be 72U/L (58 - 86). Risk to Health: Control falling out of range could lead to a delay in reporting patient results. See attached HHE. Action to be taken: - Update the affected kits with the correct target values provided. - Discuss the contents of this notice with your Medical Director. - Complete and return the response form 12187-QA to [email protected] within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organization. Please accept our apologies for any inconvenience caused. Thank you for your patience and understanding. If you have any questions or concern s, please contact Randox Technical Services.
Quantity in commerce: 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.
Product codes and lots: Catalogue Number: LAE4217 GTIN: 05055273208993 Lot Number: 1021UE (EXP: 2020-06-28)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1100-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1100-2020	Class III	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-06

Product code JJY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)