| Class 1 Device Recall AccuProbe MYCOBACTERIUM AVIUM COMPLEX IDENTIFICATION TEST | |
Date Initiated by Firm | December 30, 2008 |
Date Posted | March 10, 2011 |
Recall Status1 |
Terminated 3 on June 08, 2011 |
Recall Number | Z-1437-2011 |
Recall Event ID |
55432 |
510(K)Number | K921435 |
Product Classification |
Mycobacterium Spp. DNA-Reagents - Product Code LQF
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Product | Mycobacterium Avium Complex Culture Identification Test Identification Test Kit, 2835. |
Code Information |
Lots (batches): 555767 |
Recalling Firm/ Manufacturer |
Gen-Probe Inc 10210 Genetic Center Dr San Diego CA 92121
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For Additional Information Contact | 858-410-8703 |
Manufacturer Reason for Recall | This recall has been initiated following the identification of certain assay tubes that do not contain probe reagent. The affected kits may contain a combination of tubes with correct probe amount, partial probe amount and some probe tubes that are empty. Possible false negative results. |
FDA Determined Cause 2 | Process control |
Action | Gen-Probe issued a Recall Notice to customers recommending that they discontinue the use of the identified batch (lot) numbers listed. For customers that have used these batches and obtained negative results, they recommend that the referring physician be notified about the possibility of a false negative result.
With the Recall Notice, consignees received a Customer Response Form to complete. Gen-Probe requested that they segregate the affected batches listed on the Customer Response Form, then reconcile, and destroy all partial and/or full kits left in inventory, being sure to document the amount destroyed on the Customer Response Form. Gen-Probe should be updated via phone, fax, and email information. Customers should then sign and return the completed form to Gen-Probe via fax to 858-410-8250, or scanned and emailed to technicalsupport@genprobe.com.
The Technical Support team should be contacted for replacement kits.
Technical Support was also available for additional information at 888-484-4747 or technicalsupport@gen-probe.com. |
Quantity in Commerce | 311 kits |
Distribution | Worldwide Distribution -- USA, including Puerto Rico and countries of Australia, Guatemala, Malaysia, Bahamas, Hong Kong, Mali, Singapore, Bermuda, India, Mexico, South Africa, Canada, Israel, Netherlands, South Korea, Finland, Kuwait, Panama, Thailand, France, Latvia, and Philippines. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = LQF
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