Recall of ID-MTS Impact Pipettor (Ortho Pipettor)

DATE RECALL INITIATED:

November 22, 2002

PRODUCT / SERIAL NUMBERS

ID-MTS (Micro Typing System) Impact Pipettor, Serial Numbers:

182192	182193	182232	182238	182241	182243	182247	182259	182261	182265	182273	182275
182276	182277	182290	182292	182293	182297	182300	182304	182308	182311	182313	182314
182369	182370	182373	182374	182380	182382	182383	182384	182386	182387	182388	182393
182415	182422	182424	182430	182433	182434	182439	182442	182444	182445	182451	182455
182456	182458	182459	182462	182477	182483	182485	182487	182488	182490	182491	182492
182493	182495	182496	182498	182509	182511	182512	182513	182515	182516	182518	182519
182520	182521	182524	182525	182526	182528	182529	182530	182531	182532

282624	282626	282627	282629	282630	282631	282632	282633	282634	282635	282636	282638
282639	282640	282641	282642	282643	282644	282645	282646	282648	282650	282651	282653
282654	282656	282658	282659	282660	282661	282662	282663	282664	282665	282668	282669
282670	282671	282672	282673	282675	282676	282677	282678	282680	282682	282689	282692
282696

100383801	100383802	100383804	100383805	100383806	100383807
100383808	100383811	100383813	100383814	100576800	100576801
100576802	100576803	100576804	100576806	100576807	100576808
100576809	100576811	100576812	100576813	100576814	100576815
100576816	100576817	100576818	100576819	100576820	100576821
100576822	100677800	100677801	100677802	100677803	100677804
100677805	100677806	100677807	100677808	100677809	100677810
100677811	100677812	100677813	100677814	100677815	100677817
100677818	100677819	100677820	100677821	100677822	100677824
100677825	100956301	100956305	100956306	100956307	100956308
100956309	100956310	100956312	100956313	100956314	100956315
100956316	100956317	100956318	100956319	100956320	100956321
100956323	100956324	100984803

MANUFACTURER:

Matrix Technologies Corp
Hudson, NH

REASON:

The manufacturer has found a possibility of motor system failure in this hand held pipetting instrument. The failure is characterized by out of specification volume delivery at the 25ul and 10ul volumes, resulting in inaccurate test results. Because this type of motor failure creates inaccurate volume deliveries, it is recommended that the pipettors should not be used in critical assays and that they be returned to the manufacturer. All instruments must be decontaminated before return.

The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.