Recall Z-2487-2015 ยท JBF Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
Pointe Scientific, Inc.
Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). Also sold as individual vials Bottle: Clear glass vials Cap: Rubber seal with colored aluminum seals Glucose-6-phosphate dehydrogenase (G6PD) controls can be used to test for the quantitative and qualitative determination of G6PD in blood.
| Date | Aug 31, 2015 (initiated May 19, 2015) |
| Status | Terminated |
| Reason | A reduction in the reconstituted stability has been identified. Clinicians may notice a drop in recovery of the control after reconstitution, which could result in an out of specification result prior to the current reconstitution claim of 7 days. For this reason we suggest discontinuing use of the control set. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, POINTE SCIENTIFIC, issued a "TECHNICAL BULLETIN" on 5/19/2015, notifications were sent to the affected distributors via electronic mail. The recall notification included a description of the reason for the recall, affected product, and actions to be taken. The customers were instructed to: discontinue use of the control set and to incorporate this bulletin into your Quality Control files. The firm noted that this product has been placed on indefinite back-order and a replacement product is not currently available. For questions contact Pointe Scientific's Technical Service Depar |
| Quantity | 2772 total vials (374 kits of 6 vials, 528 invidually sold vials) |
| Distribution | Worldwide distribution: US (nationwide) including states of: PA, CA, KY, FL, NJ, DE, MI, MN,and IL; and countries of: United Arab Emirates, Austria, Italy, Israel, Greece, and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K024006 | G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE Pointe Scientific, Inc.,, Mar 31, 2003 |