Z-2487-2015Class II

Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3)...

Name: Z-2487-2015 Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3)...
Creator: Pointe Scientific, Inc.
Published: 2015-05-19
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2015-05-19 / Terminated / root cause: manufacturing process

FDA source

Pointe Scientific, Inc. began a recall of 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... on 2015-05-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2487-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-19
Posted: 2015-08-31
Terminated: 2016-05-23
Recalling firm: Horiba Instruments Incorporated
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.
Product code: JBF Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Lot: 505801 Expiration date: 2015-11 catalog numbers: G7583-CTL 7-G7583-CTL-L1 7-G7583-CTL-L2 7-G7583-CTL-L3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2487-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2487-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31

Product code JBF

K024006Class IIG6pdh, Glucose-6-Phoshate DehydrogenasePointe Scientific, Inc., / cleared 2003-03-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)