Z-1057-2019Class II

Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis...

Name: Z-1057-2019 Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis...
Creator: Randox Laboratories Ltd.
Published: 2019-02-13
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2019-02-13 / Terminated / root cause: manufacturing process

FDA source

Randox Laboratories Ltd. began a recall of Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use... on 2019-02-13. FDA classified it as Class II and gives the reason as "An error in the assignment of the control range pH in Blood Gas Control". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1057-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-13
Posted: 2019-03-26
Terminated: 2020-04-14
Recalling firm: Randox Laboratories, Limited
Product: Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes: Calcium, Chloride, Glucose, Lactate, PCO2, pH, pO2, Potassium, Sodium and Total CO2.
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: An error in the assignment of the control range pH in Blood Gas Control
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Randox Laboratories Ltd, sent an "Urgent Medical Device Correction " letter dated 2/13/2019 to its customer on 2/13/2019 via email. The letter describes the product, problem and actions to be taken. The customer was instructed todo the following: " Please replace the amended value sheet within the kit of any remaining stock. " Discuss the contents of this notice with your Medical Director. " Randox Laboratories Ltd is not recommending a review of previous results as any issue would be observed at the time of use. " Please retain this letter with your laboratory records and forward this letter to those who may have received this product. " Complete and return the response form 12187-QA to [email protected] within five working days. If you have any questions or concerns, please contact Randox Technical Services by email at [email protected], or telephone +44 (0)28 9442 2413 or Email: [email protected].
Quantity in commerce: 1 kit
Distribution: US Distribution to state of: WV
Product codes and lots: Lot Code: 184BG GTIN: 05055273227116

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1057-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1057-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-03	2019-03-26

Product code JJY

K093384Class IMission Trinity R (Level 1) (Level 2) (Level 3), (Level 1,2,3)Diamond Diagnostics, Inc. / cleared 2010-03-10

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)