Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). Also sold
FDA device recall Z-2487-2015 · posted 2015-08-31 · Terminated
Recall details
- Recalling firm
- Pointe Scientific, Inc.
- Reason for recall
- 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.
- Action taken
- 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 Department at 1-800-757-5313.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JBF
- Quantity affected
- 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.
- Date initiated
- 2015-05-19
- Date posted
- 2015-08-31
- Date terminated
- 2016-05-23
- Location
- Canton, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE (K024006) | Pointe Scientific, Inc., | 2003-03-31 |