Recall Z-1628-2010
Abbott Laboratories · initiated June 8, 2009
Product
CELL-DYN 1700, list numbers 03H5301 and 03H53-03, manufactured by Abbott Hematology, Santa Clara, CA
Codes / lots: Control Number 53278U96 53388U96 54924U96 50092U96 50230U96 50411U96 50617U96 50690U96 50770U96 50829U96 50849U96 50863U96 50867U96 50964U96 51012U96 51059U96 51160U96 51243U96 51484U96 51498U96 51509U96 51583U96 51828U96 51873U96 51886U96 51918U96 52119U96 52199U96 52294U96 52297U96 52364U96 52383U96 52390U96 52611U96 52716U96 52832U96 52894U96 53022U96 53069U96 53187U96 53238U96 53243U96 53280U96 53285U96 53307U96 53327U96 53431U96 53474U96 53481U96 53543U96 53582U96 53627U96 53647U96 53705U96 53787U96 53790U96 53796U96 53803U96 53818U96 53916U96 54017U96 54044U96 54133U96 54156U96 54177U96 54194U96 54198U96 54211U96 54266U96 54298U96 54302U96 54329U96 54371U96 54380U96 54384U96 54432U96 54448U96 54450U96 54468U96 54489U96 54499U96 54518U96 54563U96 54578U96 54587U96 54590U96 54591U96 54606U96 54611U96 54618U96 54687U96 54702U96 54732U96 54743U96 54744U96 54745U96 54747U96 54762U96 54774U96 54790U96 54806U96 54818U96 54839U96 54893U96 54904U96 54951U96 54953U96 54967U96 54968U96 54982U96 55067U96 55132U96 55147U96 55185U96 55205U96 55266U96 55299U96 55303U96 55308U96 55311U96 55344U96 55400U96 55428U96 55466U96 55510U96 55511U96 55519U96 55520U96 55522U96 55523U96 55552U96…
Reason for recall
Use of Syringe LN 04H36-01 with the Die-cast syringe drive may result in leakage, leading to delay in reporting patient results.
FDA-determined cause: Nonconforming Material/Component
Action taken
A Product Correction Letter and Customer Rely Form were sent to all currently active Cell -Dyn Sapphire customer. New customers are being notified with a Product Information Letter. For questions regarding this information, U,S, customers should call Customer Support at 1-877-4ABBOTT. Customers outside the U.S., please contact your local hematology customer support representative.
Details
- Recall number
- Z-1628-2010
- Initiated
- June 8, 2009
- Posted by FDA
- May 20, 2010
- Terminated
- December 3, 2010
- Product code
- GKZ – Counter, Differential Cell
- Quantity
- 274
- Distribution
- Worldwide distribution: United States, Canada, Mexico, Anguilla, Australia, Argentina, Belize, Bermuda, Brazil, China, Chile, Columbia, Costa Rica, Ecuador, El Salvador, Germany, Guatemala, Haiti, Honduras, Hong Kong, Japan, Paraguay, Peru, Puerto Rico, Singapore, South Korea, Uruguay, and Venezuela.
- Recalling firm
- Abbott Laboratories, Santa Clara, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1629-2010 | CELL-DYNE 1700CS (Closed Sampler), list numbers 03H57-01, 03H57-03, manufactured by…Use of Syringe LN 04H36-01 with the Die-cast syringe drive may result in leakage, leading to delay in… | 06/08/2009Terminated |
| Z-1630-2010 | CELL-DYN 1800, list numbers 07H77-01, 07H77-03, manufactured by Abbott Hematology, Santa…Use of Syringe LN 04H36-01 with the Die-cast syringe drive may result in leakage, leading to delay in… | 06/08/2009Terminated |