Recall Z-0910-2014
Nipro Diagnostics, Inc. · initiated October 2, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. Is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm.
Codes / lots: Finished Goods: KJ0731; Lot Numbers: KK0964, KL01213, KL01233-3TI, KL0267-10, KL0381-14, KL0637-2TI, KL0716TI, KL0860TI, KP0074TI.
Reason for recall
Manufactured with an incorrect factory set unit of measure.
FDA-determined cause: Software design (manufacturing process)
Action taken
Nipro Diagnostics sent an Urgent Medical Device Voluntary Recall letter dated December 31, 2013 to all affected customers. The customers were instructed to do the following: 1) Screen their inventory immediately for any of the serial numbers listed on the back of the products. 2) If they have any of the affected products, return the product by contacting Stericycle at 1-866-236-4518. 3) Complete and return the enclosed response form via fax at 1-888-358-7294. Customers with questions were instructed to call Stericycle at 1-866-236-4518. For questions regarding this recall call 954-677-9201.
Details
- Recall number
- Z-0910-2014
- Initiated
- October 2, 2013
- Posted by FDA
- February 3, 2014
- Terminated
- January 28, 2016
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- Quantity
- 105
- Distribution
- Worldwide Distribution - USA (nationwide, HI and Puerto Rico and Internationally to Canada, European Union, Jamaica, Suriname, Trinidad and Tobago, Kazakhastan, Russian, Turkey, Australia, Bangladesh, Pakistan, Cambodia, Laos, Myanmar, Thailand, Vietnam, and India.
- Recalling firm
- Nipro Diagnostics, Inc., Ft Lauderdale, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0909-2014 Class II | MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for…Manufactured with an incorrect factory set unit of measure. | 10/02/2013Terminated |