Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap. Product Usage: Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers.
FDA Recall Z-2116-2017 · Posted 2017-05-18
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Recalling FirmMedtest Holdings, Inc.
Recall StatusTerminated
Product CodeCIT
Date Initiated2012-02-15
Date Terminated2017-06-02
Product Quantity119.168L across All lots
Reason for Recall
A Discrepancy was found on Hitachi AST (HA7 61) package insert.
Limitations section indicates linearity is 500 U/L and the Performance
section linearity is listed as 0-600 U/L, which is not consistent with the
510k submission package insert.
Firm Action
Technical Bulletin Notification letter was sent 02/15/12 by email to all customers and distributors. The letter identified the affected product, problem and actions to be taken. For questions call 1-800-757-5313.
Root Cause
Error in labeling
Distribution Pattern
US Nationwide Distribution
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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