FDA (Devices) recall action 98349
The FDA (Devices) publishes a recall like this one as 20 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 20 pages.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times…
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.
Instrumentation Laboratory is recalling GEM Premier 5000 analyzers after confirmed complaints that GEM PAK cartridges may show increased Process Control Solution Not Detected errors during warm-up.
Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055360010 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055360004 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055360011 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055407508 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055407511 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Instrumentation Laboratory is recalling GEM Premier 5000 part 00055430011 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055407504 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055415004 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Instrumentation Laboratory is recalling GEM Premier 5000 part 00055445008 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Instrumentation Laboratory is recalling GEM Premier 5000 part 00055430004 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Instrumentation Laboratory is recalling GEM Premier 5000 part 00055430008 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Instrumentation Laboratory is recalling GEM Premier 5000 part 00055415011 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Instrumentation Laboratory is recalling GEM Premier 5000 part 00055415005 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055407510 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Instrumentation Laboratory is recalling GEM Premier 5000 part 00055445004 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Instrumentation Laboratory is recalling GEM Premier 5000 parts 00055445010 and 00055445011 after confirmed complaints of Process Control Solution Not Detected errors during warm-up.
Instrumentation Laboratory is recalling GEM Premier 5000 part 00055415008 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055360008 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Instrumentation Laboratory is recalling GEM Premier 5000 part 00055415010 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.