Z-2207-2019Class III

Assayed Bovine Multi-Sera Level 1, Model No. AL1027

Name: Z-2207-2019 Assayed Bovine Multi-Sera Level 1, Model No. AL1027
Creator: Randox Laboratories, Limited
Published: 2019-06-10
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2019-06-10 / Terminated / root cause: manufacturing process

FDA source

Randox Laboratories, Limited began a recall of Assayed Bovine Multi-Sera Level 1, Model No. AL1027 on 2019-06-10. FDA classified it as Class III and gives the reason as "The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL". 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-2207-2019
Classification: Class III
Status: Terminated
Initiated: 2019-06-10
Posted: 2019-08-07
Terminated: 2020-06-16
Recalling firm: Randox Laboratories, Limited
Product: Assayed Bovine Multi-Sera Level 1, Model No. AL1027
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On June 7, 2019, the firm notified customers of the recall by issuing an Urgent Medical Device Correction letter. Customers were asked to take the following actions: * Inspect your stock and quarantine affected stock on hand to prevent further use. " Discard all value sheets and replace these with the value :sheets provided. " A review of previously generated patient results is not required as control failure is evident at the time of testing. " 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. *Send a copy of the FSN to all affected customers and to those who need to be aware within your organization. If you have any questions or concerns, please contact Rand ox Technical Services.
Quantity in commerce: 4 kits (US)
Distribution: Domestic distribution to Arizona, Oregon, Washington, and West Virginia. Foreign distribution to Australia, Belarus, Canada, France, Germany, Ireland, Kenya, Korea, Lithuania, New Zealand, Nigeria, Oman, Russia, Singapore, South Africa, Sweden, Switzerland, Turkey, and UK.
Product codes and lots: 205SL

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2207-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2207-2019	Class III	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-07

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)