Recall Z-2392-2012
Instrumentation Laboratory Co. · initiated August 3, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Codes / lots: Serial Number range: 09120101 through 12060240 Distributed between: Dec 2009 to Jun 2012
Reason for recall
Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
FDA-determined cause: Software design
Action taken
The firm, Instrumentation Laboratory, sent a "Mandatory Test Parameter Upgrade" letter dated June 7, 2012 with upgrade kits P-14.8 via USPS on August 3 thru August 10 to US and Canadian customers and notified International Affiliates via e-mail on August 2, 2012. The customers were ask to complete and return the Mandatory Test Parameter Upgrade Tracking Form via fax: 781-861-4207 or email: ra-usa@ilww.com. If you have any questions, call 781-861-4204.
Details
- Recall number
- Z-2392-2012
- Initiated
- August 3, 2012
- Posted by FDA
- September 14, 2012
- Terminated
- October 2, 2015
- Product code
- GKP – Instrument, Coagulation, Automated
- Quantity
- 140 units
- Distribution
- Worldwide distribution: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, REPUBLIC OF LUXEMBOURG, MACAU, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, PERU, POLAND, PORTUGAL, ROMANIA, RUSSIAN…
- Recalling firm
- Instrumentation Laboratory Co., Bedford, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2387-2012 Class II | Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully…Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | 08/03/2012Terminated |
| Z-2388-2012 Class II | Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully…Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | 08/03/2012Terminated |
| Z-2389-2012 Class II | Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully…Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | 08/03/2012Terminated |
| Z-2390-2012 Class II | Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully…Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | 08/03/2012Terminated |
| Z-2391-2012 Class II | Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully…Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | 08/03/2012Terminated |