Recall Z-0909-2014 ยท NBW System, Test, Blood Glucose, Over The Counter
Nipro Diagnostics, Inc.
MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEbalance. 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.
| Date | Feb 3, 2014 (initiated Oct 2, 2013) |
| Status | Terminated |
| Reason | Manufactured with an incorrect factory set unit of measure. |
| Root cause | Software design (manufacturing process) |
| Action | 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. |
| Quantity | 501 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090495 | TRUEBALANCE BLOOD GLUCOSE SYSTEM Home Diagnostics, Inc., Mar 27, 2009 |