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U.S. Department of Health and Human Services

Class 2 Device Recall Pointe Scientific

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 Class 2 Device Recall Pointe Scientificsee related information
Date Initiated by FirmJune 09, 2006
Date PostedSeptember 30, 2006
Recall Status1 Terminated 3 on November 20, 2007
Recall NumberZ-1543-06
Recall Event ID 35499
510(K)NumberK972333 
Product Classification Ammonia/alcohol assay - Product Code JIX
ProductAmmonia/alcohol Control Set for the quantitative determination of ammonia/alcohol in blood, Manufactured for Pointe Scientific, Inc.; Catalog number A7504-CTL.
Code Information Lot 522202, exp. 7/06.
FEI Number 1827821
Recalling Firm/
Manufacturer		 Pointe Scientific, Inc.
5449 Research Dr
Canton MI 48188-2261
For Additional Information Contact
734-487-8300
Manufacturer Reason
for Recall		Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.
FDA Determined
Cause 2		Other
ActionConsignees were notified via recall letter dated 6/9/06 and a second letter dated 6/21/06 extending the recall to additional products/lots, to cease using the products, conduct a recall to the user level, destroy products on hand and to notify the firm via the response form of the amount destroyed for replacement purposes.
Quantity in Commerce44 units
DistributionWorldwide distribution ---- including USA and countries of Canada, Ecuador, Germany, Greece, India, Mexico, Peru, Poland, Portugal, Trinidad, United Arab Emirates and United Kingdom.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JIX
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