Recall Z-2125-2013— Siemens Healthcare Diagnostics, Inc.
Class I · Terminated
Class I FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2013-08-21, terminated 2014-05-15. It names 2 FDA 510(k) clearances: K020246, K020249. 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 gram-negative bacteria.. Reason: 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..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2013-08-21
- Terminated
- 2014-05-15
- Firm location
- West Sacramento, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K020246 — MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25, 1-32 UG/ML)
- K020249 — MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML)
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 gram-negative bacteria.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.