FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2487-2015
- Recalling firm
- Pointe Scientific, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2015-05-19
- Posted
- 2015-08-31
- Terminated
- 2016-05-23
- 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 Department at 1-800-757-5313.
- 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.
- Lot, serial or model codes
- Lot: 505801 Expiration date: 2015-11 catalog numbers: G7583-CTL 7-G7583-CTL-L1 7-G7583-CTL-L2 7-G7583-CTL-L3
- 510(k) numbers
- ["K024006"]
- PMA numbers
- not on file
- Product code
- JBF
- Firm FEI
- 1827821
- Firm city
- Canton
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28