Date Initiated by Firm | June 19, 2014 |
Date Posted | August 08, 2014 |
Recall Status1 |
Terminated 3 on February 23, 2016 |
Recall Number | Z-2169-2014 |
Recall Event ID |
68617 |
510(K)Number | K092705 |
Product Classification |
Clinical sample concentrator - Product Code JJH
|
Product | 5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System). The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the m2000rt and the m2000sp instruments.
The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the m2000rt and the m2000sp instruments. |
Code Information |
Unique Product Identifier: 04J71-20; Serial Numbers: 56944001, 57026001, 57059001, 57673001 |
Recalling Firm/ Manufacturer |
Abbott Molecular 1300 E Touhy Ave Des Plaines IL 60018-3315
|
For Additional Information Contact | Ms. Jean Leete 224-361-7274 |
Manufacturer Reason for Recall | Abbott Molecular identified that some of the 5 ml Reaction Vessels (RVs) contained in lots 56944001, 57026001, 57059001, and 57673001 (original vendor lot 2198077) may have an insufficient rim. An RV with an insufficient rim may not be held securely in the 1 mL Subsystem Carrier. This may cause the RV to be seated incorrectly in the carrier or drop through it. |
FDA Determined Cause 2 | Employee error |
Action | Abbott sent a Field Correction Recall / Urgent Field Safety Notice dated July 3, 2014, to all affected customers. June 19, 2014 were sent to all customers. The letters instructed customers to: 1) examine their inventories, 2) remove any of the affected lots, and 3) contact their Abbott Molecular Representativeat 1-800-553-7042 to coordinate replacement.
Customers were also instructed to review this information with laboratory personnel and retain the communication for future reference.
For questions regarding this recall call 224-361-7274 |
Quantity in Commerce | 1,688,000 reaction vessels |
Distribution | Worldwide Distribution - USA (nationwide) and Internationally to:
AUSTRALIA
AUSTRIA
BELGIUM
BENIN
CAMEROON
CHINA
ETHIOPIA
FINLAND
FRANCE
GERMANY
INDIA
INDONESIA
IRELAND
ISRAEL
ITALY
KENYA
MALAYSIA
MALAWI
MALI
NETHERLANDS
NEW ZEALAND
NORWAY
PAKISTAN
PHILIPPINES
POLAND
PORTUGAL
RUSSIA
SENEGAL
SINGAPORE
SOUTH AFRICA
SOUTH KOREA
SPAIN
SWEDEN
SWITZERLAND
TAIWAN
THAILAND
TURKEY
UKRAINE
UNITED KINGDOM
VIETNAM |
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 = JJH
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