FDA (Devices) recall action 66058

Siemens Healthcare Diagnostics, Inc. recalled 11 products on 2013-09-18

The FDA (Devices) publishes a recall like this one as 11 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 11 pages.

Products: 11
Announced: 2013-09-18
Critical: 4
Units: 345,600

Why these products were recalled

Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–11 of 11

CriticalFDA (Devices)··2013-09-18
Siemens Microscan Synergies Plus Negative Urine Combo 5 Recall
Siemens is recalling Microscan Synergies Plus Negative Urine Combo 5 panels due to confirmed false susceptibility results for imipenem and meropenum.
Product
Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacte
Category
Distribution
17 states
SevereFDA (Devices)··2013-09-18
Siemens Microscan Synergies Plus Negative Combo 2 Recall for Misreads
Siemens Healthcare Diagnostics is recalling Microscan Synergies Plus Negative Combo 2 panels due to confirmed false susceptible and intermediate misreads for Imipenem and meropenum.
Product
Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.
Category
Distribution
17 states
CriticalFDA (Devices)··2013-09-18
Siemens Microscan plus Negative Urine Combo 4 Recalled for Misreads
Siemens Healthcare Diagnostics is recalling Microscan plus Negative Urine Combo 4 panels due to confirmed false susceptible and intermediate misreads for specific antibiotics.
Product
Microscan plus Negative Urine Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gra
Category
Distribution
17 states
HighFDA (Devices)··2013-09-18
Siemens MicroscanrapID/S panels recalled for antimicrobial misreads
Siemens Healthcare Diagnostics is recalling MicroscanrapID/S panels due to confirmed false susceptible and intermediate results for imipenem and meropenum.
Product
MicroscanrapID/S panels NC3.11 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative
Category
Distribution
17 states
HighFDA (Devices)··2013-09-18
Siemens Microscan rapID/S panels recalled for false susceptibility results
Siemens Healthcare Diagnostics is recalling Microscan rapID/S panels due to confirmed false susceptibility and intermediate misreads for imipenem and meropenum.
Product
Microscan rapID/S panels NC3.12 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative
Category
Distribution
17 states
CriticalFDA (Devices)··2013-09-18
Siemens Microscan Plus Negative Breakpoint Combo 4 Recalled for Misreads
Siemens Healthcare Diagnostics is recalling Microscan plus Negative Breakpoint Combo 4 panels due to confirmed false susceptible and intermediate misreads for specific antibiotics.
Product
Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification fo
Category
Distribution
17 states
HighFDA (Devices)··2013-09-18
Siemens Microscan Synergies Plus Negative Urine Combo 2 Recall
Siemens Healthcare Diagnostics is recalling Microscan Synergies Plus Negative Urine Combo 2 panels due to confirmed false susceptible and intermediate misreads for imipenem and meropenum.
Product
Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteri
Category
Distribution
17 states
HighFDA (Devices)··2013-09-18
Siemens Microscan rapID/S panels recalled for false susceptibility results
Siemens Healthcare Diagnostics is recalling Microscan rapID/S panels due to confirmed false susceptible and intermediate misreads for imipenem and meropenum.
Product
Microscan rapID/S panels NC3.33 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative
Category
Distribution
17 states
HighFDA (Devices)··2013-09-18
Siemens Microscan Synergies Plus Negative Urine Combo 1 Recalled for Misreads
Siemens Healthcare Diagnostics is recalling Microscan Synergies Plus Negative Urine Combo 1 panels due to confirmed false susceptible and intermediate results for imipenem and meropenum.
Product
Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteri
Category
Distribution
17 states
CriticalFDA (Devices)··2013-09-18
Siemens Microscan Plus Negative Combo 3 Recalled for Misreads
Siemens Healthcare Diagnostics is recalling Microscan plus Negative Combo 3 panels due to confirmed false susceptible and intermediate misreads for imipenem and meropenum.
Product
Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-nega
Category
Distribution
17 states
LowFDA (Devices)··2013-09-18
Siemens Microscan Synergies Plus Negative Panels Recalled for Misreads
Siemens is recalling Microscan Synergies Plus Negative panels due to confirmed false susceptible and intermediate results for imipenem and meropenum.
Product
Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative ba
Category
Distribution
17 states