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U.S. Department of Health and Human Services

Class 2 Device Recall Pointe Scientific G6PD Screening Controls

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  Class 2 Device Recall Pointe Scientific G6PD Screening Controls see related information
Date Initiated by Firm May 19, 2015
Date Posted August 31, 2015
Recall Status1 Terminated 3 on May 23, 2016
Recall Number Z-2487-2015
Recall Event ID 71988
510(K)Number K024006  
Product Classification Glucose-6-phosphate dehydrogenase (erythrocytic), screening - Product Code JBF
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.
Code Information Lot: 505801 Expiration date: 2015-11 catalog numbers: G7583-CTL 7-G7583-CTL-L1 7-G7583-CTL-L2 7-G7583-CTL-L3 
Recalling Firm/
Manufacturer		 Pointe Scientific, Inc.
5449 Research Dr
Canton MI 48188-2261
For Additional Information Contact Customer Support
800-445-9853
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JBF and Original Applicant = POINTE SCIENTIFIC, INC.
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