Z-2557-2019 Class III Terminated
FDA device recall Z-2557-2019 was initiated by Randox Laboratories Ltd. on July 25, 2019 and is designated Class III. Reason for recall: Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+. The recall status is terminated (terminated December 3, 2020). Affected quantity: 1 kit.
Recall Details
- Product Type
- Devices
- Report Date
- October 2, 2019
- Initiation Date
- July 25, 2019
- Termination Date
- December 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 kit
Product Description
Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips.
Reason for Recall
Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.
Distribution Pattern
US Nationwide distribution including the states of IN, WV.
Code Information
Lot: 1020UC Exp. Date: 28 May 2020