Ammonia/alcohol Control Set for the quantitative determination of ammonia/alcohol in blood, Manufactured for Pointe Scientific, Inc.; Catalog number A7504-CTL.
FDA Recall Z-1543-06 · Posted 2006-09-30
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Recalling FirmPointe Scientific, Inc.
Recall StatusTerminated
Product CodeJIX
Date Initiated2006-06-09
Date Terminated2007-11-20
Product Quantity44 units
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.
Firm Action
Consignees 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.
Root Cause
Other
Distribution Pattern
Worldwide distribution ---- including USA and countries of Canada, Ecuador, Germany, Greece, India, Mexico, Peru, Poland, Portugal, Trinidad, United Arab Emirates and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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