HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinas
FDA device recall Z-0736-2016 · posted 2016-02-01 · Terminated
Recall details
- Recalling firm
- Instrumentation Laboratory Co.
- Reason for recall
- This Lot is not meeting labeled on-board instrument stability claims of 5 days.
- Action taken
- Instrumentation Laboratory Co. sent an " Urgent Medical Device Removal" letter dated December 2015, was sent on December 18, 2015. via USPS to US and Canadian customers. The notification requires US and Canadian customers to respond using a Mandatory Response Tracking Form. A Field Safety Notice was e-mailed on December 18, 2015, to the affected IL affiliates, notifying them of the product lot removal due to a stability issue and requesting them to translate the Field Safety Notice, to notify their Competent Authorities and to provide the notification to their affected customer base and secondary distributors. For further questions, please call 1(800) 955-9525.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GGP
- Quantity affected
- Domestic: 108 kits, Foreign: 197 kits
- Distribution
- Worldwide Distribution - US Distribution and to the countries of : Canada, Argentina, Austria, Belgium, Brazil, China, Czech Republic, France, Germany, Hong Kong, Italy, Lithuania, Panama, Poland, Rus
- Date initiated
- 2015-12-18
- Date posted
- 2016-02-01
- Date terminated
- 2017-08-30
- Location
- Bedford, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IL TEST PLASMINOGEN (K981200) | Instrumentation Laboratory CO | 1998-05-26 |