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Showing 67501–67520 of 68218 results

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Abbott Laboratories HPD/ADD/GPRD: ARCHITECT Folate Manual Diluent, List 6C12-50; One 4 mL b...

The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.

FDADec 16, 2003IN• Abbott Laboratories HPD/ADD/GPRD

Greiner VACUETTE North America: Holdex + Butterfly, Blood Collection Set, Single use only...

Product may have a defective connection.

FDADec 16, 2003IN, NY, TX• Greiner VACUETTE North America

Abbott Laboratories HPD/ADD/GPRD: IMx Folate Ion Capture Component Set, list 2220-88; the s...

The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.

FDADec 16, 2003IN• Abbott Laboratories HPD/ADD/GPRD

Abbott Laboratories HPD/ADD/GPRD: IMx Folate Medium Control, list 2220-11; the pack contain...

The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.

FDADec 16, 2003IN• Abbott Laboratories HPD/ADD/GPRD

Mentor Texas, Inc: Mentor Smooth Round Becker 50 Expander, manufactured by M...

Device was distributed without the dome part accessory, part number 350-DOMPK

FDADec 16, 2003Nationwide• Mentor Texas, Inc

Abbott Laboratories HPD/ADD/GPRD: Folate Low and High Controls, list 9C13-10; the pack cont...

The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.

FDADec 16, 2003IN• Abbott Laboratories HPD/ADD/GPRD

Abbott Laboratories HPD/ADD/GPRD: ARCHITECT Folate Specimen Diluent, List 6C12Y, 5.5 mL (10...

The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.

FDADec 16, 2003IN• Abbott Laboratories HPD/ADD/GPRD

Abbott Laboratories HPD/ADD/GPRD: ARCHITECT Folate Low and Medium Controls, List 6C12-10; t...

The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.

FDADec 16, 2003IN• Abbott Laboratories HPD/ADD/GPRD

Abbott Laboratories HPD/ADD/GPRD: IMx Folate Mode 1 Calibrator Pack, list 2220-40, the pack...

The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.

FDADec 16, 2003IN• Abbott Laboratories HPD/ADD/GPRD

Abbott Laboratories HPD/ADD/GPRD: ARCHITECT Folate High Controls, List 6C12-11; the kit con...

The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.

FDADec 16, 2003IN• Abbott Laboratories HPD/ADD/GPRD

Abbott Laboratories HPD/ADD/GPRD: AxSYM Folate Medium Control Pack , list 3C81-11, the pack...

The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.

FDADec 16, 2003IN• Abbott Laboratories HPD/ADD/GPRD

Abbott Laboratories HPD/ADD/GPRD: AxSYM Folate Specimen Diluent, list 3C81-50, 10 mL bottle...

The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.

FDADec 16, 2003IN• Abbott Laboratories HPD/ADD/GPRD

Abbott Laboratories HPD/ADD/GPRD: AxSYM Folate RBC Protein Diluent Pack, list 3C81-65; one ...

The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.

FDADec 16, 2003IN• Abbott Laboratories HPD/ADD/GPRD

Abbott Laboratories HPD/ADD/GPRD: IMx Specimen Diluent Pack, list 2220-50; 1 - 10 mL bottle...

The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.

FDADec 16, 2003IN• Abbott Laboratories HPD/ADD/GPRD

Baxter Healthcare Corp. Rt: Micromix BCR Compounder, product code 2M8297; a pharmacy ...

The compounder may omit an ingredient during the compounding process.

FDADec 16, 2003UT, WI• Baxter Healthcare Corp. Rt

Roche Diagnostics Corp.: Roche brand OMNI 8 clinical chemistry analyzer; catalog n...

If the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume.

FDADec 15, 2003Nationwide• Roche Diagnostics Corp.

Abbott Laboratories HPD/ADD/GPRD: ARCHITECT Free T4 Calibrator Kit, list 7G96-01; the kit ...

The calibrator lots may yield Free T4 values that are depressed.

FDADec 15, 2003Nationwide• Abbott Laboratories HPD/ADD/GPRD

Roche Diagnostics Corp.: Roche brand OMNI 7 clinical chemistry analyzer; catalog n...

If the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume.

FDADec 15, 2003Nationwide• Roche Diagnostics Corp.

Invacare Corporation: Invacare 2G Tarsys Seating System, Model 2GT.

The weld joints on the seat back may fail and cause possible injury to the patient.

FDADec 15, 2003Nationwide• Invacare Corporation

Becton Dickinson & Co.: Directigen (TM) EZ RSV In-Vitro Diagnostic test kit, cont...

Diagnostic test kit may exhibit false positive results.

FDADec 15, 2003Nationwide• Becton Dickinson & Co.

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