FDA regulators put their highest-risk Class I label on Siemens’ (NYSE:SI) recall of more than 78,000 of its MicroScan Synergies plus and MicroScan rapID/S plus antimicrobial tests, warning that false test results could hinder patient care.
The 5 lots of Siemens’ tests, which were distributed between July 11, 2001 and Aug. 2, 2013, were recalled for reporting false susceptible and false intermediate results for imipenem and meropenem antimicrobial susceptibility testing when using the MicroScan WalkAway System, the FDA said.
Siemens representatives didn’t respond to a request for comment.
These antibiotic agents are used to treat a number of serious microbial infections that are resistant to the antibiotic of choice, and are commonly used to treat hospital-acquired and mixed-bacterial infections, according to the Centers for Disease Control & Prevention.
Use of the defective Siemens tests could result in treatment with an inappropriate antibiotic or a delay in initiating appropriate therapy, the FDA warned this week.
Siemens initiated the recall on August 21 when it issued an Urgent Field Safety Notice to customers, naming the defective products with instructions to "suppress all reporting of sensitive and intermediate results" for imipenem and meropenem, and recommending review of previous test results, patient follow-up, and repeat testing.
The company also asked customers to confirm receipt of the safety notice and said it will add an Important Product Information notice to future kits, according to the agency.
The recall comes on the heels of some inner turmoil faced by the German healthcare giant, including the ouster of former CEO Peter Löscher in the wake of several missed earnings reports and profit warning letters for Siemens.
SI shares were up 1.9% today, trading at $111.11 as of about 1:40 p.m.