openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 5
MicroScan Pos Combo Panel Type 21, Part No. B1017-201 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213 in a portion of affected lots of MicroScan Pos Combo and MicroScan Pos Breakpoint Combo panels. The expected result is positive.
These labels are deterministic app interpretations, not FDA categories.
Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213 in a portion of affected lots of MicroScan Pos Combo and MicroScan Pos Breakpoint Combo panels. The expected result is positive.
Code information
2016-05-05 Part No. B1017-201
Distribution pattern
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.
device · product 2 of 5
MicroScan Pos Combo Panel Type 33, Part No. B1017-211 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213 in a portion of affected lots of MicroScan Pos Combo and MicroScan Pos Breakpoint Combo panels. The expected result is positive.
These labels are deterministic app interpretations, not FDA categories.
Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213 in a portion of affected lots of MicroScan Pos Combo and MicroScan Pos Breakpoint Combo panels. The expected result is positive.
Code information
2016-04-29 2016-05-04 Part No. B1017-211
Distribution pattern
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.
device · product 3 of 5
MicroScan Pos Combo Panel Type 34, Part No. B1017-214 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213 in a portion of affected lots of MicroScan Pos Combo and MicroScan Pos Breakpoint Combo panels. The expected result is positive.
These labels are deterministic app interpretations, not FDA categories.
Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213 in a portion of affected lots of MicroScan Pos Combo and MicroScan Pos Breakpoint Combo panels. The expected result is positive.
Code information
2016-04-29 2016-05-06 Part No. B1017-214
Distribution pattern
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.
device · product 4 of 5
MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213 in a portion of affected lots of MicroScan Pos Combo and MicroScan Pos Breakpoint Combo panels. The expected result is positive.
These labels are deterministic app interpretations, not FDA categories.
Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213 in a portion of affected lots of MicroScan Pos Combo and MicroScan Pos Breakpoint Combo panels. The expected result is positive.
Code information
2016-04-30 Part No. B1017-202
Distribution pattern
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.
device · product 5 of 5
MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213 in a portion of affected lots of MicroScan Pos Combo and MicroScan Pos Breakpoint Combo panels. The expected result is positive.
These labels are deterministic app interpretations, not FDA categories.
Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213 in a portion of affected lots of MicroScan Pos Combo and MicroScan Pos Breakpoint Combo panels. The expected result is positive.
Code information
2016-05-06 Part No. B1017-206
Distribution pattern
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.
