Pointe Scientific, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2487-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: May 19, 2015

Date Posted: September 9, 2015

Recall Number: Z-2487-2015

Event ID: 71988

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.

Status: Terminated

Product Quantity: 2772 total vials (374 kits of 6 vials, 528 invidually sold vials)

Code Information:

Lot: 505801 Expiration date: 2015-11 catalog numbers: G7583-CTL 7-G7583-CTL-L1 7-G7583-CTL-L2 7-G7583-CTL-L3

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated