Recall Z-1797-2018 ยท CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Diagnostic Hybrids, Inc.
MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.
| Date | Jul 14, 2016 |
| Status | Terminated |
| Reason | There is a possibility of low volume and/or leaking standard bottles. |
| Root cause | Process control |
| Action | Customers were contacted via telephone and a letter dated 7/14/16. The letter instructed customers to review their inventory for the specified lot number, check for any low-volume or leaking standards, and contact the recalling firm if necessary. |
| Quantity | 1004 |
| Distribution | The products were distributed to the following US states: CA, CT, GA, IL, KY, MA, MD, MO, PA, TX, WA, and WI. The products were distributed to the following foreign countries: Australia, Brazil, Canada, China, Costa Rica, India, Japan, Mexico, The Philippines, Russia, South Korea, South Africa, Sw |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981373 | ALKPHASE-B ASSAY KIT Metra Biosystems, Inc., May 27, 1998 |